Clinical Data Management

When it comes to clinical trial success, data integrity is key. Pentara clinical data management experts are detailed, flexible, and committed to providing the highest quality, integrity, and security for our clients. Using Industry-leading data capture (EDC) technologies, Pentara provides end-to-end clinical data management support from eCRF design through database lock and final study archival.

Working hand-in-hand with you and study site personnel, our reliable team ensures Active communication from the moment you sign with the team. Working together to curate a desirable database that results in clean, quality data. Pentara clinical data management uniquely utilizes the skill sets of each team member across all departments to coordinate quality-first data that is fully compatible with SDTM and ADaMs.

Clinical Data Management Services:
  • Data Management Trial Master File Set-up and Maintenance
  • CRF Design and Development
  • Interactive CRF Review Meeting
  • CRF Completion Guidelines Development
  • Data Management Plan Development
  • EDC System Training for Sites and Monitors
  • User administration
  • Database design development
  • Clinical database creation and validation
  • Development of Custom Status Reports
  • Query Management
  • Adverse event, Concomitant Medication and Medical History Coding
  • Import, Integration, and Cleaning of Electronic Data (Lab, ECG, PK, etc.)
  • Continuous Data Cleaning
  • Study Metrics provided through an online accessible Dashboard
  • SAE Reconciliation between Safety and Clinical Databases
  • Database Lock
  • Site CRF Archival
  • Project Change Requests
  • Study Closeout